Safety Pen Needle for Single Use, Insulin Pen Needles

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Berpu Medical Technology Co., Ltd. % Diana Hong General Management Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China ### Re: K212514 Trade/Device Name: Safety Pen Needle for Single Use, Insulin Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 23, 2022 Received: March 30, 2022 ### Dear Diana Hong: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K212514 Device Name Safety Pen Needle for Single Use Insulin Pen Needle #### Indications for Use (Describe) The Safety Pen Needle for Single Use is intended for use with pen injector devices for the subcutaneous injection of insulin. The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. Type of Use (Select one or both, as applicable) _ Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K212514 - 1. Date of Preparation: 04/28/2022 - 2. Sponsor Identification ## Berpu Medical Technology Co., Ltd. NO.14 Xingji Road, Yongxing Street, Longwan District, Wenzhou, Zhejiang, China 325000 Establishment Registration Number: 3004496829 Contact Person: Buxin Yu Position: Management Representative Tel: +86-577-86651999 Fax: +86-577-86630389 Email: ybx@berpu.com - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person) ### Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net {4}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: Safety Pen Needle for Single Use Insulin Pen Needle Common Name: Antistick needle and needle Regulatory Information Classification Name: Needle, Hypodermic, Single Lumen; Classification: II; Product Code: FMI; Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital Indication for use: The Safety Pen Needle for Single Use is intended for use with pen injector devices for the subcutaneous injection of insulin. The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. #### Device Description The devices are provided in two types of configurations: Safety Pen Needle for Single Use and Insulin Pen Needle. The Safety Pen Needle for Single Use is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of a needle cap, needle hub, safety protective cover, self-destruction seat and sealed paper. The safety protective cover is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. | Gauge | Length | Wall Type | |-------|--------|------------------------------------------| | 34G | 4mm | Regular wall, Thin wall, Extra-thin wall | | 34G | 5mm | Regular wall, Thin wall, Extra-thin wall | | 34G | 6mm | Regular wall, Thin wall, Extra-thin wall | | 34G | 8mm | Regular wall, Thin wall, Extra-thin wall | | 33G | 4mm | Regular wall, Thin wall, Extra-thin wall | | 33G | 5mm | Regular wall, Thin wall, Extra-thin wall | | 33G | 6mm | Regular wall, Thin wall, Extra-thin wall | | 33G | 8mm | Regular wall, Thin wall, Extra-thin wall | {5}------------------------------------------------ | 32G | 4mm | Regular wall, Thin wall, Extra-thin wall,<br>Ultra-thin wall | |-----|-----|--------------------------------------------------------------| | | 5mm | Regular wall, Thin wall, Extra-thin wall | | | 6mm | Regular wall, Thin wall, Extra-thin wall | | | 8mm | Regular wall, Thin wall, Extra-thin wall | | 31G | 4mm | Regular wall, Thin wall, Extra-thin wall | | | 5mm | Regular wall, Thin wall, Extra-thin wall | | | 6mm | Regular wall, Thin wall, Extra-thin wall | | | 8mm | Regular wall, Thin wall, Extra-thin wall | | 30G | 4mm | Regular wall, Thin wall, Extra-thin wall | | | 5mm | Regular wall, Thin wall, Extra-thin wall | | | 6mm | Regular wall, Thin wall, Extra-thin wall | | | 8mm | Regular wall, Thin wall, Extra-thin wall | | 29G | 4mm | Regular wall, Thin wall, Extra-thin wall | | | 5mm | Regular wall, Thin wall, Extra-thin wall | | | 6mm | Regular wall, Thin wall, Extra-thin wall | | | 8mm | Regular wall, Thin wall, Extra-thin wall | The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of protective cap, needle tube, needle protective cover and sealed paper. | Gauge | Length | Wall Type | |-------|--------|------------------------------------------| | 34G | 4mm | Regular wall, Thin wall, Extra-thin wall | | 34G | 5mm | Regular wall, Thin wall, Extra-thin wall | | 34G | 6mm | Regular wall, Thin wall, Extra-thin wall | | 34G | 8mm | Regular wall, Thin wall, Extra-thin wall | | 33G | 4mm | Regular wall, Thin wall, Extra-thin wall | | 33G | 4mm | Regular wall, Thin wall, Extra-thin wall | | 33G | 5mm | Regular wall, Thin wall, Extra-thin wall | | 33G | 6mm | Regular wall, Thin wall, Extra-thin wall | | 33G | 8mm | Regular wall, Thin wall, Extra-thin wall | | 28G | 4mm | Regular wall, Thin wall | | 28G | 5mm | Regular wall, Thin wall | | 28G | 6mm | Regular wall, Thin wall | {6}------------------------------------------------ | 8mm | Regular wall, Thin wall | |------|-------------------------| | 10mm | Regular wall, Thin wall | | 13mm | Regular wall, Thin wall | The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 106. - ડ. Identification of Predicate Device 510(k) Number: K181447 Product Name: Safety insulin needle for single use - 6. Non-Clinical Test Conclusion Non-clinical tests were conducted to verify that the proposed device met all design specifications in order to demonstrate that the subject device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - A ISO 10993-5: 2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity - > ISO 10993-10: 2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization. - > ISO 10993-11: 2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity - > ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials - > ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection - > ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility) - > ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration - > ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods - > ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices - A ISO 11608-2 Second edition 2012-04-01, Needle-based injection systems for medical use -Requirements and test methods - Part 2: Needles - > ISO 23908:2011 Sharps injury protection - Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling - A ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Test of Ethylene Oxide Residues. - USP<85> Bacterial Endotoxins Test A - USP<151> Pyrogen Test A {7}------------------------------------------------ Physical, Mechanical, and Chemical testing listed in following table were performed on the proposed device. The test results show that the device conforms with the requirements of related standards. | Dimensions | Clause 4.2 of ISO 11608-2:2012 | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Determination of flow rate through the needle | Clause 4.3 of ISO 11608-2:2012 | | Bond between hub and needle tube | Clause 4.4 of ISO 11608-2:2012 | | Needle points | Clause 4.5 of ISO 11608-2:2012 | | Freedom from defects | Clause 4.6 of ISO 11608-2:2012 | | Lubrication | Clause 4.7 of ISO 11608-2:2012 | | Dislocation of measuring point at patient end | Clause 4.8 of ISO 11608-2:2012 | | Determination of functional compatibility with needle-based injection systems | Clause 4.9 of ISO 11608-2:2012 | | Ease of assembly and disassembly | Clause 4.10 of ISO 11608-2:2012 | | Cleanliness | Clause 4.3 of ISO 7864:2016 | | Limits for acidity or alkalinity | Clause 4.4 of ISO 7864:2016 | | Limits for extractable metals | Clause 4.5 of ISO 7864:2016 | | Size designation | Clause 4.6 of ISO 7864:2016 | | Colour coding | Clause 4.7 of ISO 7864:2016 | | Needle hub | Clause 4.8 of ISO 7864:2016 | | Needle Cap | Clause 4.9 of ISO 7864:2016 | | Needle tube | Clause 4.10 of ISO 7864:2016 | | Needle point | Clause 4.11 of ISO 7864:2016 | | Bond between hub and needle tube | Clause 4.12 of ISO 7864:2016 | | Patency of lumen | Clause 4.13 of ISO 7864:2016 | | Surface finish and appearance | Clause 5.2 of ISO 9626:2016 | | Cleanliness | Clause 5.3 of ISO 9626:2016 | | Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 | | Size designation | Clause 5.5 of ISO 9626:2016 | | Dimensions | Clause 5.6 of ISO 9626:2016 | | Stiffness | Clause 5.8 of ISO 9626:2016 | | Resistance to breakage | Clause 5.9 of ISO 9626:2016 | | Resistance to corrosion | Clause 5.10 of ISO 9626:2016 | | EO residue | ISO 10993-7:2008 | | ECH residue | ISO 10993-7:2008 | | Bacteria Endotoxin Limit | USP <85> | | Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests<br>were performed on aging samples to verify the<br>claimed shelf life of the device | Particulate testing USP <788> {8}------------------------------------------------ Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection and sterility maintenance. Sterile barrier package integrity testing was performed on the proposed devices which includes visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15), and dye penetration testing (ASTM F1929-15). Sterilization and shelf life testing, listed in following table, were performed on the proposed devices. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life testing results showed that the device can maintain its performance during the claimed shelf life of 5 years. #### Biocompatibility testing The contact classification of the proposed devices are Externally Communicating - Blood path, indirect for a Prolonged contact duration. The proposed devices were evaluated for the following tests. The results for the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed devices. - > Cytotoxicity, - > Sensitization, - A Intracutaneous reactivity, - > Acute Systemic Toxicity, - > Hemolysis, - > Pyrogen, - > Subacute Toxicity #### Simulated Clinical Study A simulated clinical study was performed on proposed device according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005, and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results {9}------------------------------------------------ demonstrated that the proposed device met the pre-established criteria. Safety Feature Test The safety feature test was performed on the Safety Pen Needle for Single Use and predicate device to evaluate safety feature. The results demonstrated that both the proposed device and predicate device met the acceptance criteria. - 7. Clinical Test Conclusion No clinical study is included in this submission. {10}------------------------------------------------ #### 8. Summary of Technology Characteristics | Table 1 Comparison of Safety Pen Needle for Single Use | | | | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------| | ITEM | Proposed Device | Predicate Device | Remark | | | K212514 | K181447 | | | Product | Safety Pen Needle for Single Use | Safety insulin needle for single use | / | | Product Code | FMI | FMI | Same | | Regulation No. | 21 CRF 880.5570 | 21 CRF 880.5570 | Same | | Class | Class II | Class II | Same | | Indication for<br>Use | The Safety Pen Needle for Single Use<br>is intended for use with pen injector<br>devices for the subcutaneous injection<br>of insulin. | The Safety insulin needle for single<br>use is intended for use with pen<br>injector devices for the subcutaneous<br>injection of insulin. | Same | | Configuration | Needle tube | Needle Tube | Different | | | Needle hub | Hub | | | | Safety protective cover | Safety protective cover | | | | Self-destruction seat | Self-destruction seat | | | | Hub sheath | Hub sheath | | | | Sealed paper | Sealed paper | | | | / | Safety seat | | | | / | Spring | | | Operation Mode | For manual use only | For manual use only | Same | | Environment of<br>use | In hospital or in the home<br>environment | In hospital or in the home<br>environment | Same | | Method of<br>attachment to<br>pen injector | Through threaded connection | Through threaded connection | Same | | Safety Feature | Prevent from needlestick | Prevent from needlestick | Same | | Safety feature<br>activation forces | Average at 3.71N | Average at 3.73N | Similar | | Single Use | Single Use | Single Use | Same | | Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | Needle Gauge | 29G, 30G, 31G, 32G, 33G, 34G | 29G, 30G, 31G, 32G, 33G, 34G | Same | | Needle Length | 4mm, 5mm, 6mm, 8mm | 4mm, 5mm, 6mm, 8mm | Same | | Needle<br>Performance | Complied with<br>ISO 7864,<br>ISO 9626,<br>ISO 11608-2 | Complied with<br>ISO 7864,<br>ISO 9626,<br>ISO 11608-2 | Same | | Material | | | | | Table 1 | Comparison of Safety Pen Needle for Single Use | |---------|------------------------------------------------| |---------|------------------------------------------------| {11}------------------------------------------------ | Safety | | | | |------------------|-------------------------------|------------------------------|-----------| | protective cover | Polypropylene (PP) | Polypropylene | Different | | Needle hub | Polypropylene (PP) | Polypropylene | | | Self-destruction | Polypropylene (PP) | MABS | | | seat | | | | | Hub sheath | Polypropylene (PP) | | | | Needle tube | Stainless Steel (SUS304) | | | | Sealed paper | Medical paper (Blister Paper) | | | | Adhesive | UV adhesive | | | | Lubricant | Polydimethylsiloxane | | | | Biocompatibility | | | | | Cytotoxicity | No cytotoxicity | No cytotoxicity | Same | | Irritation | No intracutaneous reactivity | No intracutaneous reactivity | | | Sensitization | No sensitization | No skin sensitization | | | Systemic | No systemic toxicity | No systemic toxicity | | | Toxicity | | | | | Hemolysis | No Hemolysis | No Hemolysis | | | Pyrogen | No Pyrogen | No Pyrogen | | | Sterilization | | | | | Method | EO Sterilized | EO Sterilized | Same | | SAL | 10-6 | 10-6 | Same | | Endotoxin Limit | 20 EU per device | 20 EU per device | Same | #### Different Analysis - Configuration The configuration of the Safety Pen Needle for Single Use is similar to the configurations of predicate device. Although the components of the proposed device and the predicate device are not identical, this difference does not affect the indication for use of the device. In addition, a series of performance tests have been conducted on the proposed device to demonstrate that the proposed device meets the requirements of the relevant standards. Therefore, it can be considered that the minor differences in the components will not affect the Substantial Equivalence (SE) between the proposed and predicate device. #### Similar Analysis - Safety feature activation forces The activation force of the Safety Pen Needle for Single Use is similar to the predicate device. The activation force difference between the two devices is 0.02N. In addition, activation force met the acceptance criteria. Therefore, the minor difference in activation force will not affect the Substantial Equivalence (SE) between the proposed and predicate device. ### Different Analysis -Material The materials for Safety Pen Needle for Single Use is different from the predicate device. However, biocompatibility testing has been performed on the proposed device and the results do not show any {12}------------------------------------------------ adverse effect. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device. | ITEM | Proposed Device | Predicate Device | Remark | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------| | | K212514 | K181447 | | | Product | Insulin Pen Needle | Safety insulin needle for single use | / | | Product Code | FMI | FMI | Same | | Regulation No. | 21 CRF 880.5570 | 21 CRF 880.5570 | Same | | Class | Class II | Class II | Same | | Indication for Use | The Insulin Pen Needle is intended<br>for use with pen injector devices for<br>the subcutaneous injection of insulin. | The Safety insulin needle for single<br>use is intended for use with pen<br>injector devices for the subcutaneous<br>injection of insulin. | Same | | Configuration | Needle tube<br>Needle hub<br>Hub sheath<br>Needle protective cover<br>Sealed paper<br>/<br>/<br>/ | Needle Tube<br>Hub<br>Safety protective cover<br>Self-destruction seat<br>Hub sheath<br>Sealed paper<br>Safety seat<br>Spring | Different | | Operation Mode | For manual use only | For manual use only | Same | | Environment of use | In hospital or in the home<br>environment | In hospital or in the home<br>environment | Same | | Method of<br>attachment to<br>pen injector | Through threaded connection | Through threaded connection | Same | | Single Use | Single Use | Single Use | Same | | Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | Needle Gauge | 28, 33G, 34G | 29G, 30G, 31G, 32G, 33G, 34G | Different | | Needle Length | 4mm, 5mm, 6mm, 8mm, 10mm,<br>13mm | 4mm, 5mm, 6mm, 8mm | Different | | Needle<br>Performance | Complied with<br>ISO 7864,<br>ISO 9626,<br>ISO 11608-2 | Complied with<br>ISO 7864,<br>ISO 9626,<br>ISO 11608-2 | Same | | Material | | | | | Needle hub | Polypropylene (PP) | Polypropylene | Different | | Hub sheath | Polypropylene (PP) | 304 Stainless Steel | | | Sealed paper | Medical paper (Blister Paper) | Polypropylene | | | Needle<br>protective cover | Polypropylene (PP) | MABS | | | Needle tube | Stainless Steel (SUS304) | | | | Adhesive | UV adhesive | | | | Lubricant | Polydimethylsiloxane | | | | Biocompatibility | | | | | Cytotoxicity | No cytotoxicity | No cytotoxicity | Same | | Irritation | No intracutaneous reactivity | No intracutaneous reactivity | Same | | Sensitization | No sensitization | No skin sensitization | Same | | Systemic<br>Toxicity | No systemic toxicity | No systemic toxicity | Same | | Hemolysis | No Hemolysis | No Hemolysis | Same | | Pyrogen | No Pyrogen | No Pyrogen | Same | | Sterilization | | | | | Method | EO Sterilized | EO Sterilized | Same | | SAL | 10-6 | 10-6 | Same | | Endotoxin Limit | 20 EU per device | 20 EU per device | Same | Table 2 Comparison of Insulin Pen Needle {13}------------------------------------------------ ### Different Analysis -Configuration The components of Insulin Pen Needle are different to that of predicate device. The proposed device does not have a safety mechanism; however, the presence or absence of a safety mechanism does not affect the indication for use and the performance of the device. In addition, a series of performance tests have been conducted on the proposed device and the results showed that the product meets the requirements of the relevant standards. Therefore, this difference does not affect the Substantial Equivalence (SE) between the proposed and predicate device. #### Different Analysis – Needle Gauge The needle gauge of Insulin Pen Needle is different from predicate devices. The proposed 33G and 34G can be covered by the predicate device, while the proposed 28G is out of the specification range of predicate device. However, all the needle size of proposed device has been tested. The test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference does not affect the Substantial Equivalence (SE) between the proposed and predicate device. #### Different Analysis - Needle length Compared with the predicate device, the Insulin Pen Needle has the additional 10mm and 13mm length specifications. However, these two additional length specifications have been tested. The test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference does not affect the Substantial Equivalence (SE) between the proposed and predicate device. {14}------------------------------------------------ Different Analysis -Material The material for Safety Pen Needle for Single Use is different from the predicate device. However, biocompatibility testing has been performed on the proposed device and the results do not show any adverse effect. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device. - 9. Substantially Equivalent (SE) Conclusion The non-clinical tests demonstrate that the Safety Pen Needle for Single Use and Insulin Pen Needle are Substantially Equivalent (SE) to the legally marketed predicate device cleared under K181447.